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Last Updated: May 11, 2021

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CLINICAL TRIALS PROFILE FOR BICALUTAMIDE

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505(b)(2) Clinical Trials for Bicalutamide

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT01416870 Bioequivalence of Bicalutamide New Formulation in Japan Terminated AstraZeneca Phase 1 2010-07-01 The purpose of this study is to investigate the bioequivalence of Bicalutamide new formation with Casodex commercial tablet (80mg) in Japanese healthy male subjects
New Formulation NCT01416883 Oral Mucosal Absorption Study of Bicalutamide New Formulation Terminated AstraZeneca Phase 1 2010-07-01 The purpose of this study is to investigate the presence or absence of oral mucosal absorption of bicalutamide after ICI176,334.1 is given to Japanese healthy male subjects
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Bicalutamide

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002633 Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer Completed Eastern Cooperative Oncology Group Phase 3 1995-03-01 RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether hormone therapy plus surgery is more effective than hormone therapy plus radiation therapy for prostate cancer. PURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV prostate cancer.
NCT00002633 Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer Completed Medical Research Council Phase 3 1995-03-01 RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether hormone therapy plus surgery is more effective than hormone therapy plus radiation therapy for prostate cancer. PURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV prostate cancer.
NCT00002633 Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer Completed National Cancer Institute (NCI) Phase 3 1995-03-01 RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether hormone therapy plus surgery is more effective than hormone therapy plus radiation therapy for prostate cancer. PURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV prostate cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Bicalutamide

Condition Name

Condition Name for Bicalutamide
Intervention Trials
Prostate Cancer 87
Adenocarcinoma of the Prostate 10
Prostatic Neoplasms 8
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Condition MeSH

Condition MeSH for Bicalutamide
Intervention Trials
Prostatic Neoplasms 122
Adenocarcinoma 15
Breast Neoplasms 10
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Clinical Trial Locations for Bicalutamide

Trials by Country

Trials by Country for Bicalutamide
Location Trials
United States 790
Canada 98
United Kingdom 26
Japan 26
Italy 22
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Trials by US State

Trials by US State for Bicalutamide
Location Trials
New York 29
California 29
Texas 29
Maryland 29
Michigan 25
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Clinical Trial Progress for Bicalutamide

Clinical Trial Phase

Clinical Trial Phase for Bicalutamide
Clinical Trial Phase Trials
Phase 4 7
Phase 3 42
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Bicalutamide
Clinical Trial Phase Trials
Completed 57
Recruiting 24
Active, not recruiting 23
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Clinical Trial Sponsors for Bicalutamide

Sponsor Name

Sponsor Name for Bicalutamide
Sponsor Trials
National Cancer Institute (NCI) 48
AstraZeneca 15
Radiation Therapy Oncology Group 10
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Sponsor Type

Sponsor Type for Bicalutamide
Sponsor Trials
Other 156
Industry 72
NIH 48
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